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Cardiovascular Benefit of Colchicine in Relation to Baseline Risk: A Secondary Analysis of the LoDoCo2 Trial

J Am Heart Assoc. 2025 May 15:e038687. doi: 10.1161/JAHA.124.038687. Online ahead of print.

ABSTRACT

BACKGROUND: The LoDoCo2 (Low-Dose Colchicine 2) trial showed that colchicine reduced the risk for cardiovascular events in patients with chronic coronary syndrome. Current guidelines recommend colchicine use in selected high-risk patients. The aim of this secondary analysis was to explore the relative and absolute benefits of colchicine according to baseline risk.

METHODS: The LoDoCo2 trial randomized 5522 patients to colchicine 0.5 mg or placebo. The primary end point was a composite of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. First, a LoDoCo2 risk score was developed by Cox regression to identify high-risk features for the primary end point. Second, the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention was applied to explore robustness of findings.

RESULTS: In the LoDoCo2 risk score, high-risk features were age ≥75, diabetes, and current smoker. In high-risk (≥1 high-risk feature), compared with low-risk (0 high-risk features) patients, colchicine was associated with consistent relative (high risk: hazard ratio [HR], 0.72 [95% CI, 0.56-0.94] versus low risk: HR, 0.67 [95% CI, 0.52-0.88]; P for interaction=0.73) and absolute benefits (high risk: HR, -1.33 [95% CI, -2.38 to -0.27] versus low risk: HR, -0.93 [95% CI -1.57 to -0.30] events per 100 person-years). Using the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention, consistent relative and absolute benefits were found in high-, intermediate-, and low-risk patients.

CONCLUSIONS: In patients with chronic coronary syndrome, the relative and absolute benefits of colchicine were consistent in those at high, intermediate, and low risk for cardiovascular events. These findings support the use of colchicine across the spectrum of baseline risk.

REGISTRATION: URL: https://www.anzctr.org.au; Unique identifier: 12614000093684.

PMID:40371626 | DOI:10.1161/JAHA.124.038687

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Endoscopic ultrasound with bronchoscope fine-needle biopsy in the diagnosis of suspected malignant pulmonary lesions with crown-cut needle: a retrospective study

Minerva Med. 2025 May 15. doi: 10.23736/S0026-4806.25.09633-8. Online ahead of print.

ABSTRACT

BACKGROUND: The role of Transesophageal bronchoscopic ultrasound-guided fine needle aspiration (EUS-B-FNA) in the diagnosis of malignant pulmonary lesions adjacent to the esophagus is a well-known procedure with high diagnostic yield. Moreover, it is indicated for lung cancer staging. Franseen needle tip is a crown-cut needle that allow to obtain tissue cores and provide huge amount of tissue for pathologist’s evaluation, moving from fine needle aspiration (FNA) to fine needle biopsy (FNB). Few data about EUS-B-FNB and Franseen needle tip are available in Literature.

METHODS: Between May 2022 and June 2024, 33 patients with lymphadenopathy who underwent EUS-B with Franseen needle tip were consecutively enrolled. Chest CT scan was performed prior procedure. Lymphnodes’ dimension at imaging and EUS-B were recorded. EUS-B-TBNB was performed with 22G or 25G needle size. Diagnostic yield and specimen adequacy (SA) for predictive markers were evaluated.

RESULTS: 22G needle was used in 18 patients and 25G in 15, and no statistically significant differences were observed between sex and age in the two groups. Overall Diagnostic Yield was 91% (30/33), with no statistically significant differences between 22G and 25G needle group (89% and 93%, respectively). SA for predictive markers was achieved in 20 of 23 patients (87%) with cancer diagnosis, with no significant differences between 22G and 25G group (P=0.59). No adverse events were observed.

CONCLUSIONS: EUS-B-FNB is a safe and an effective diagnostic method that should be performed in every bronchoscopy suite. Franseen needle tip provides high quality samples for pathologists, avoiding procedure repetition and/or more invasive procedures.

PMID:40371614 | DOI:10.23736/S0026-4806.25.09633-8

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Changes in Protein Expression of Renal Drug Transporters and Drug-Metabolizing Enzymes in Autosomal Dominant Polycystic Kidney Disease Patients

Clin Pharmacol Ther. 2025 May 15. doi: 10.1002/cpt.3715. Online ahead of print.

ABSTRACT

Autosomal dominant polycystic kidney disease is the most prevalent inherited kidney disease and leads to bilateral kidney enlargement and progressive loss of renal function, often over decades. Comorbidities include hypertension, flank pain, and bacterial infections. The condition often necessitates prolonged multidrug therapy. Given the kidneys’ critical role in drug excretion, the progressive functional impairment in the disease can lead to complications such as drug overdosing and unexpected levels of drug-drug interactions. Studies of drug-metabolizing enzyme and transporter expression in this patient group remain scarce. We conducted comprehensive global liquid chromatography-tandem mass spectrometry proteomic analyses of microsomal and cytosolic fractions from early-stage (chronic kidney disease stage: 13, n = 16) and end-stage autosomal dominant polycystic kidney disease patients (chronic kidney disease stage: 5, n = 14), comparing them with age-matched healthy controls (n = 11). In the early-stage ADPKD samples, most drug-metabolizing enzymes and drug transporters did not differ significantly from the healthy controls. Exceptions were EPHX2 and SULT1C2 in the cytosolic fraction, which showed a more than 2-fold decrease in abundance (P < 0.05). In contrast, the end-stage ADPKD kidney samples showed a decrease in the abundance of most measured proteins. Several drug-metabolizing enzymes, including CYP4F2, UGT1A6, UGT1A9, and UGT2B7, exhibited statistically significant reductions (P < 0.05). Among the drug transporters, OAT1, OAT3, and OCT2 were below the limit of quantification in most ES-ADPKD samples. MDR1 was the only efflux drug transporter consistently measured, with an average abundance of 1.24 pmol/mg microsomal protein across all samples.

PMID:40371605 | DOI:10.1002/cpt.3715

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One-Year Follow-Up of Acne Vulgaris Patients Treated With Nonablative Monopolar Radiofrequency: Efficacy and Safety Assessment

Lasers Surg Med. 2025 May 15. doi: 10.1002/lsm.70026. Online ahead of print.

ABSTRACT

BACKGROUND: Moderate-to-severe acne vulgaris (AV) remains a therapeutic challenge, often demonstrating resistance to standard interventions, including topical agents, oral antibiotics, and systemic retinoids. Nonablative monopolar radiofrequency (NMRF) offers a promising alternative by delivering controlled dermal heating without epidermal disruption. Initial findings from the authors demonstrated significant reductions in inflammatory lesion counts and sebum production following two NMRF sessions administered 4 weeks apart, with results sustained up to 6 months. This updated study extends the evaluation to include additional clinical assessments at 9- and 12-month posttreatment, providing further insights into the long-term efficacy and safety of this modality.

OBJECTIVE: To evaluate the extended efficacy and safety of NMRF therapy in the management of moderate-to-severe AV, incorporating follow-up assessments at 9- and 12-month posttreatment.

METHODS: The study included 20 participants with moderate-to-severe AV who had been previously enrolled in the authors’ initial investigation. All participants underwent two NMRF sessions, spaced 4 weeks apart, as per the original protocol. Follow-up assessments were conducted at 9- and 12-month posttreatment. Lesions were categorized as inflammatory (papules, pustules, nodules, cysts) or noninflammatory (comedones). Sebum production was measured quantitatively using a Sebumeter at each follow-up visit. Patient-reported outcomes, including perceived improvement and satisfaction, were also documented.

RESULTS: Of the initial 20 participants, 11 completed the 12-month follow-up. Clinical assessments revealed statistically significant reductions in both inflammatory and noninflammatory lesion counts, with the most substantial decreases observed in papules, pustules, nodules, and cysts. Sebum levels continued to decline consistently over the extended follow-up period. Patient satisfaction scores remained high at both time points, and no significant adverse effects were reported, reinforcing the favorable safety and tolerability profile of NMRF therapy.

CONCLUSION: NMRF is a safe, effective, and minimally invasive treatment for moderate-to-severe AV. The 1-year follow-up data highlight its potential as a long-term treatment option, demonstrating sustained reductions in lesion counts and sebum production following a two-session course.

PMID:40371601 | DOI:10.1002/lsm.70026

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Effectiveness of Photobiomodulation and Exercise-Based Rehabilitation on Pain and Functional Recovery in Patients With Rotator Cuff Pathology

Wound Repair Regen. 2025 May-Jun;33(3):e70043. doi: 10.1111/wrr.70043.

ABSTRACT

Rotator cuff (RC) pathology encompasses a wide range of conditions, which include bursitis, tendinitis, tendinosis, partial thickness tears and full-thickness tears. To treat painful musculoskeletal problems, low-level laser therapy (LLLT) has been employed as a non-pharmacological alternative. Photobiomodulation (PBM), which uses light-emitting diodes (LEDs) and other photo-emitting devices, is a minimally invasive approach used to treat a wide range of conditions. The purpose of this pre-post study design is to evaluate the effectiveness of PBM and exercise-based rehabilitation on pain and functional recovery in patients with RC pathology. Twenty of the thirty-seven patients who were tested for shoulder disorders and found to have RC pathology were included in the study. The patients’ pain levels were measured using the Numerical Pain Rating Scale (NPRS) both at baseline and 6 weeks later. The mean ± standard deviation of NPRS was calculated, data was checked for normal distribution, and the Wilcoxon rank test was conducted to compare the values. Our study showed a statistically significant reduction in pain scores from baseline (7.33 ± 0.79) to 6 weeks (2.50 ± 0.69), p < 0.001 of PBM and exercise-based rehabilitation. The knowledge about the evidence regarding the effectiveness of PBM, along with exercise-based rehabilitation, is critical.

PMID:40371595 | DOI:10.1111/wrr.70043

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Association of Cardiovascular-Kidney-Metabolic Syndrome With Cognitive Decline and Dementia: The ARIC Study Insights

J Am Heart Assoc. 2025 May 15:e038445. doi: 10.1161/JAHA.124.038445. Online ahead of print.

ABSTRACT

BACKGROUND: Cardiovascular-kidney-metabolic (CKM) syndrome is an emerging clinical entity emphasizing the need for a holistic approach to patient care. The relationship between CKM syndrome and cognitive decline or dementia remains undetermined.

METHODS: A total of 10 426 participants in the ARIC (Atherosclerosis Risk in Communities) study, classified into 4 CKM risk categories at baseline (visit 2: 1990-1992): low risk (≤5%), borderline risk (5%-7.4%), intermediate risk (7.5%-19.9%), and high risk (≥20%), were used to investigate the associations between CKM risk and cognitive decline or dementia using regression analysis.

RESULTS: Elevated CKM risk level is significantly associated with increased risks of cognitive decline and dementia incidence. Each 1-unit increase in CKM risk level is linked to a 6% higher risk of dementia progression in the fully adjusted model.

CONCLUSIONS: These findings highlight a strong association between CKM syndrome and cognitive decline or incident dementia, underscoring the importance of early interventions.

PMID:40371582 | DOI:10.1161/JAHA.124.038445

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Rising Threat: Long-Term Trends in the Incidence and Mortality of Thymic Epithelial Tumor

Cancer Med. 2025 May;14(10):e70968. doi: 10.1002/cam4.70968.

ABSTRACT

INTRODUCTION: An upward trend in the incidence of thymic epithelial tumors (TETs) has been reported over the past few decades, but because of its rarity, little is currently known about its epidemiological trends. This study examined temporal trends in the incidence and mortality of TETs in the US and explored these trends in population subgroups while investigating important factors that influence their prognosis.

METHODS: A retrospective, population-based study was conducted using nationally representative data from the Surveillance, Epidemiology, and End Results program, and 4979 patients diagnosed with TETs from 2000 to 2020 were evaluated. Associated population data were used to determine age-adjusted incidence and mortality, and 5-year TET-specific mortality (SM). Trends were assessed for the entire cohort, as well as for particular subgroups, including thymoma and thymic carcinoma.

RESULTS: From 2000 to 2020, the overall incidence and mortality of TETs were 2.769 and 1.203 per million person-years, respectively. Both the age-adjusted incidence and mortality of TETs increased over the study period, with increases occurring across almost all ethnic groups, histological subtypes, and stages. Multivariate analysis revealed that age, World Health Organization histological type (B1, B2, and B3 thymoma and thymic carcinoma), Masaoka-Koga stage (IIB and III/IV), maximum tumor diameter (5-10 and > 10 cm), surgery, and chemotherapy were independently associated with TET-SM.

CONCLUSIONS: The incidence and mortality of TETs have steadily increased over time, and these trends might be related to the widespread use of computed tomography for lung cancer screening and the increasing number of TETs found incidentally. The study also identified several important factors independently associated with TET-SM, suggesting that early diagnosis and surgical intervention are critical to achieving good prognoses.

PMID:40371577 | DOI:10.1002/cam4.70968

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The Lack of Neurofeedback Training Regulation Guidance and Process Evaluation May be a Source of Controversy in Post-Traumatic Stress Disorder-Neurofeedback Research: A Systematic Review and Statistical Analysis

Brain Connect. 2025 May 15. doi: 10.1089/brain.2024.0084. Online ahead of print.

ABSTRACT

Objectives: Neurofeedback (NF) based on brain-computer interface (BCI) is an important direction in adjunctive interventions for post-traumatic stress disorder (PTSD). However, existing research lacks comprehensive methodologies and experimental designs. There are concerns in the field regarding the effectiveness and mechanistic interpretability of NF, prompting this study to conduct a systematic analysis of primary NF techniques and research outcomes in PTSD modulation. The study aims to explore reasons behind these concerns and propose directions for addressing them. Methods: A search conducted in the Web of Science database up to December 1, 2023, yielded 111 English articles, of which 80 were excluded based on predetermined criteria irrelevant to this study. The remaining 31 original studies were included in the literature review. A checklist was developed to assess the robustness and credibility of these 31 studies. Subsequently, these original studies were classified into electroencephalogram-based NF (EEG-NF) and functional magnetic resonance imaging-based NF (fMRI-NF) based on BCI type. Data regarding target brain regions, target signals, modulation protocols, control group types, assessment methods, data processing strategies, and reported outcomes were extracted and synthesized. Consensus theories from existing research and directions for future improvements in related studies were distilled. Results: Analysis of all included studies revealed that the average sample size of PTSD patients in EEG and fMRI NF studies was 17.4 (SD 7.13) and 14.6 (SD 6.37), respectively. Due to sample and neurofeedback training protocol constraints, 93% of EEG-NF studies and 87.5% of fMRI-NF studies used traditional statistical methods, with minimal utilization of basic machine learning (ML) methods and no studies utilizing deep learning (DL) methods. Apart from approximately 25% of fMRI NF studies supporting exploratory psychoregulatory strategies, the remaining EEG and fMRI studies lacked explicit NF modulation guidance. Only 13% of studies evaluated NF effectiveness methods involving signal classification, decoding during the NF process, and lacking in process monitoring and assessment means. Conclusion: In summary, NF holds promise as an adjunctive intervention technique for PTSD, potentially aiding in symptom alleviation for PTSD patients. However, improvements are necessary in the process evaluation mechanisms for PTSD-NF, clarity in NF modulation guidance, and development of ML/DL methods suitable for PTSD-NF with small sample sizes. To address these challenges, it is crucial to adopt more rigorous methodologies for monitoring NF, and future research should focus on the integration of advanced data analysis techniques to enhance the effectiveness and precision of PTSD-NF interventions. Impact Statement The implications of this study are to address the limited application of Neurofeedback training (NFT) in post-traumatic stress disorder (PTSD) research, where a significant portion of the approaches, foundational research, and conclusions lack consensus. There is a notable absence of retrospective statistical analyses on NFT interventions for PTSD. This study provides a comprehensive statistical analysis and discussion of existing research, offering valuable insights for future studies. The findings hold significance for researchers, clinicians, and practitioners in the field, providing a foundation for informed, evidence-based interventions for PTSD treatment.

PMID:40371570 | DOI:10.1089/brain.2024.0084

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Has regional decentralisation saved lives during the COVID-19 pandemic?

Health Econ Policy Law. 2025 May 15:1-16. doi: 10.1017/S1744133125000052. Online ahead of print.

ABSTRACT

We examine the impact of decentralisation on COVID-19 mortality and various health outcomes. Specifically, we investigate whether decentralised health systems, which facilitated greater regional participation and information sharing, were more effective in saving lives. Our analysis makes three contributions. First, we draw on evidence from several European countries to assess whether the decentralisation of health systems influenced COVID-19 mortality rates. Second, we explore the regional disparities in one of the most decentralised health systems, Spain, to untangle some of the determinants shaping health outcomes. Third, we estimate the regional loss of Quality Adjusted Life Years (QALYs) due to COVID-19 mortality, broken down by the wave of the pandemic. Our findings suggest that coordinated decentralisation played a critical role in saving lives throughout the COVID-19 pandemic.

PMID:40371549 | DOI:10.1017/S1744133125000052

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Drug survival and predictor factors for discontinuation of first-line biologic therapy in rheumatoid arthritis: data from a real-world single-centre study

Clin Exp Rheumatol. 2025 May 8. doi: 10.55563/clinexprheumatol/5kr6kk. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the survival of the first biological disease-modifying anti-rheumatic drug (bDMARD) in a Greek rheumatoid arthritis (RA) cohort and determine factors influencing drug retention rates.

METHODS: Patients from the Pathophysiology Clinic of LAIKON University Hospital who received their first bDMARD were stratified into anti-tumour necrosis factor (anti-TNF) and non-anti-TNF groups, and whether an event occurred. An event was defined as discontinuation due to inefficacy or adverse event (AE), including severe infections. Drug survival curves were calculated using the Kaplan-Meier method. Analysis was performed using t-tests, chi-square tests, and Cox proportional hazards in STATA, with a 5% significance level.

RESULTS: We included 724 patients, mostly females (79%), with a median age of 48.6 ±15.7 years at diagnosis. More than half were positive for RF and/or ACPA, with a baseline DAS28-ESR of 4.9 ±1.5. The most used anti-TNFs were etanercept (n=261), infliximab (n=177), adalimumab (n=148), while rituximab (RTX, n=40) was the most used non-anti-TNF. RTX recipients experienced one-half of the events compared to those in the anti-TNF group (IRR 0.52, 95%CI: 0.27 to 0.92). After 276 months, 223 patients discontinued treatment due to inefficacy and 187 due to AEs. Most withdrawals (73.3%) occurred within the first 50 months regardless of cause. RTX was found to be protective against treatment failure, while both RF and ACPA positivity were identified as potential risk factors for discontinuation due to either failure or AE.

CONCLUSIONS: Only 26.7% of patients remained on first bDMARD after 50 months, with those receiving RTX less likely to discontinue for any reason. RF and/or ACPA positivity could be potential risk factors for discontinuation due to AEs or inefficacy.

PMID:40371548 | DOI:10.55563/clinexprheumatol/5kr6kk